Budesonide Inhalation

Product NDC: 60687-524
Requested package NDC: 60687-524-83
11-digit product format: 606870524
Labeler code: 60687
Product ID: 60687-524_3765f418-7255-94d8-e063-6394a90ab595
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Budesonide Inhalation
Dosage form: SUSPENSION
Route: RESPIRATORY (INHALATION)
Labeler: American Health Packaging
Application: ANDA210897
Marketing category: ANDA
Marketing start: 2020-01-06
Substance: BUDESONIDE
Active strength: .5 mg/2mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210897-001	BUDESONIDE	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN		2018-11-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A210897-001	AN

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210897-001	BUDESONIDE	0.5MG/2ML	SUSPENSION / INHALATION	AN	2018-11-09	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A210897-001	AN	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210897-001	AN	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210897-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210897-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210897-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210897-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210897-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210897-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210897-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210897-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210897-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210897-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210897-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210897-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210897-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210897-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210897-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210897-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210897-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210897-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210897-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210897-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210897-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210897-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210897-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210897-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210897-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210897-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210897-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210897-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210897-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210897-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210897-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210897-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210897-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210897-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210897-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210897-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210897-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210897-001	AN	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Budesonide Inhalation
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUDESONIDE	.5 mg/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Q3OKS62Q6X	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
351109	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
45e5f304-1177-42a2-91c9-3ed1a9c9f8e6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7816cdf6-b925-4282-bedd-11ae25d518a1	Product name	1	20250116
d17a61d0-e77b-4bcb-ad22-343ff1a3ef4d	Product name	2	20240424
9ab9f611-cedd-47ea-a83c-0489c8c04fc6	Product name	1	20231006
c76bcd0f-25eb-471e-b970-1956c95c26c5	Product name	1	20230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
a03aea00-1d8b-bfad-a82e-f52f68676f63	Product name	2	20221216
54a29484-7dde-4771-9547-005149321621	Product name	1	20220720
793b53dd-c0ea-da17-9ac0-fb5c4a6e0743	Product name	5	20211018
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
218c043e-94e5-4e66-a363-d0d446485bc6	Product name	2	20210512
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9a	Product name	1	20210204
5e2e25b6-cb6b-8e81-afe3-62c3e2cd56c7	Product name	9	20210127
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
da63bc8c-2e89-4044-89d6-1facbff5474e	Product name	1	20200121
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
899766bc-33ce-8154-910d-12cb0889fb56	Product name	2	20150106

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
60687-524-79	Budesonide Inhalation	1 in 1 POUCH	SUSPENSION	1	5
60687-524-79	Budesonide Inhalation	2 mL in 1 AMPULE	SUSPENSION	2	5
60687-524-83	Budesonide Inhalation	30 in 1 CARTON	SUSPENSION	30	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-524-79	ML - Milliliter	60687-524	70b3203a-f74c-41e4-8443-e46798cca207	1	2020-01-03
60687-524-83	ML - Milliliter	60687-524	cd5818d3-3f33-40a5-9e7f-779cbdfce626	1	2020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60687-524	BUDESONIDE INHALATION SUSPENSION [AMERICAN HEALTH PACKAGING]	4	Current NDC, Legacy NDC, 3 package rows	20240731_45e5f304-1177-42a2-91c9-3ed1a9c9f8e6.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
budesonide inhalation	BUDESONIDE INHALATION	Preferred Pharmaceuticals, Inc.	dd74e446-7c1b-4f02-9c73-ba716572ee77	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210897 application number: ANDA210897
Budesonide Inhalation	BUDESONIDE INHALATION	American Health Packaging	45e5f304-1177-42a2-91c9-3ed1a9c9f8e6	2025-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210897 application number: ANDA210897 ndc (package): 60687-524-83 ndc (product): 60687-524 ndc11 (package): 60687052483
budesonide inhalation	BUDESONIDE INHALATION	A-S Medication Solutions	87048fa9-3391-4f30-801d-b96ca0132f56	2025-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210897 application number: ANDA210897
budesonide inhalation	BUDESONIDE INHALATION	Lupin Pharmaceuticals, Inc.	944cbb7c-b41d-4a6d-8a93-2e646365c982	2025-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210897 application number: ANDA210897

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Q3OKS62Q6X	BUDESONIDE	51333-22-3	BUDESONIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
351109	budesonide 0.5 MG in 2 ML Inhalation Suspension	PSN	45e5f304-1177-42a2-91c9-3ed1a9c9f8e6	5
351109	budesonide 0.25 MG/ML Inhalation Suspension	SCD	45e5f304-1177-42a2-91c9-3ed1a9c9f8e6	5
351109	budesonide 0.5 MG per 2 ML Inhalation Suspension	SY	45e5f304-1177-42a2-91c9-3ed1a9c9f8e6	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60687-524-83	60687052483	30 POUCH in 1 CARTON (60687-524-83) / 1 AMPULE in 1 POUCH (60687-524-79) / 2 mL in 1 AMPULE	30 pouch	2020-01-06	0000-00-00	No	No	Current